Tuesday, November 23, 2010

Regeneron Sues for Declaratory Judgment That VEGF Trap Does Not Infringe Genentech Patents

On November 19, Regeneron sued Genentech in the US District Court for the Southern District of New York seeking a declaration that no activities relating to the Regeneron VEGF Trap infringe any claim of US patent numbers 5,952,199; 6,100,071; 6,383,486; 6,897,294; and 7,771,721 (all assigned to Genentech according to the complaint). The complaint is available here, compliments of PriorSmart.com.

Vascular Endothelial Growth Factor, or VEGF, is a protein growth factor which is required for formation of blood vessels, a process known as angiogenesis. According to Wikipedia:

In the adult human, angiogenesis is only consistently active in the gut - however in pathological cases such as cancer, where a solid tumor grows rapidly and therefore requires a blood supply, there is also active angiogenesis. Therefore, the blockade of VEGF is a potentially viable strategy for treating solid tumors.

Regeneron has developed a chimeric (i.e., fusion) protein, which it refers to as VEGF Trap (aflibercept), that comprises the extra-cellular domain of VEGF Receptor (the growth factor's natural receptor). The extra-cellular domain of the receptor is used to bind, or "trap" VEGF, and thereby keep it from binding receptors on the surface of blood vessels. Regeneron is working towards FDA approval to market VEGF Trap for a number of ophthalmologic and oncology indications. According to the complaint, the company intends to submit a Biologic License Application before the end of the second quarter of 2011 to market the product for a wet age-related macular degeneration. Yesterday, Regeneron stock rose 19.7% after the company announced positive Phase 3 clinical trial results for the drug (see here).

Genentech has developed an antibody called Avastin that binds VEGF. Avastin is already approved for the treatment of colon cancer. The five Genentech patents which are the subject of the declaratory judgment action are directed toward chimeric VEGF receptor proteins capable of binding VEGF.

2 comments:

If the conservative congress is so concerned about excessive regulation of business than they ought to revamp the entire patent and tradmark system to make it harder for the holders of these patents and trademarke to sue for violations. Everybody pays for the legation one way or another. Many businesses are seriously harmed by having to defend themselves against lawsuits brought by all the holders of these unreasonable patents and trademarks. Consumers are forced to pay much higher prices for the patented and trademarked services and products than would otherwise be the case. higher prices in many cases for products and services that would cost much less if they were not protected by patents or trademarks.

About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.